Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06671158

Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change

Although measurement-based care (MBC) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. Questions remain regarding MBC's unique added value compared to usual care.

Thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. This study implemented MBC in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework.

Researchers will compare three groups: 1) the Measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. Participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Depressive Disorder Anxiety Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carilion Mental Health

Roanoke, Virginia, 24018, United States

About this study

Measurement-based care (MBC) is an evidenced-based practice, involving routine completion of patient-reported outcome measures and collaborative discussions between clinician and client to inform clinical decision-making and facilitate improvement. Despite its known benefits, such as reduced dropout rates and improved treatment outcomes, questions remain regarding MBC's unique effectiveness compared to standard care. Furthermore, mechanisms of change on how MBC actually works in treatment have yet to be fully investigated. Thus, the current study aims to conduct a randomized control trial to evaluate the added value of MBC, by comparing an MBC+psychotherapy group, a psychotherapy-only group, and a waitlist group with no interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary concern and referral reason for seeking psychotherapy are either depressive- or anxiety-related symptoms and/or psychological distress, using minimum scores as follows: PHQ-9 (score > 4), GAD-7 (score > 4), and BASE-6 (score > 18), and
  • being 18 years old or older.

Exclusion criteria

  • Severe physical or psychiatric conditions that would hinder the treatment (e.g., clients with acute psychosis, intellectual disability, or neurocognitive disorders who do not have the capacity to undergo informed consent and participate in the study);
  • currently receiving psychotherapy through another source;
  • significant suicidal/homicidal risk that would need immediate intervention;
  • do not have ability complete Patient-Rated Outcome Measures (PROMs) either in person or remotely

Treatment and study plan

Psychotherapy

Behavioral

Individual psychotherapy for weekly 12-sessions

Primary outcomes

  1. Brief Adjustment Scale-6 (BASE-6)

    Time frame: Completed weekly through study completion, an average of 3 to 4 months

    Self-report questionnaire designed to measure general psychological adjustment and functioning of adult-aged individuals Minimum score: 6 Maximum score: 42 A higher score indicates severe difficulty in psychological adaptation and functioning/worse outcome

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Completed weekly through study completion, an average of 3 to 4 months

    Evaluate depression symptoms Minimum score: 0 Maximum score: 27 A higher score indicates more severe depression/worse outcome

  3. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Completed weekly through study completion, an average of 3 to 4 months

    evaluate anxiety symptoms Minimum score: 0 Maximum score: 21 A higher score indicates more severe anxiety/worse outcome

Secondary outcomes

  1. World Health Organization Quality of Life-Brief (WHOQOL-BREF)

    Time frame: Pre-post, through study completion, an average of 3 to 4 months

    This is a self-report measure designed to assess an individual's quality of life and well-being across four domains, including physical health, psychological well-being, social relationships, and environmental conditions Minimum score: 0 Maximum score: 100 A higher score indicates a higher quality of life/better outcome

  2. Working Alliance Inventory-Short Form Revised (WAI-SR)

    Time frame: Completed monthly, through study completion, an average of 3 to 4 months

    The WAI-SR is a self-report measure of the strengths of the therapeutic alliance that clients perceive.

    Minimum score: 12 Maximum score: 60 A higher score indicates a stronger working alliance between the provider and the patient / better outcome

  3. Vanderbilt Psychotherapy Process Scale - Patient version (VPPS)

    Time frame: Completed every 6 weeks; through study completion, an average of 3 to 4 months

    The VPPS-P is a patient-report measure consisting of 42 items with five subscales, including therapist exploration, negative relationship, patient psychic distress, patient participation, therapist warmth and friendliness, and patient dependency.

    Minimum score: 42 Maximum score: 210 A higher score indicates better outcome

Other outcomes

  1. Clinical Global Impressions - Severity of Illness (CGI-S)

    Time frame: Pre-post, through study completion, an average of 3 to 4 months

    Clinical impressions of the clinician's view on the client's global functioning, the overall severity of symptoms (CGI-S) Minimum score: 1 Maximum score: 7 A higher score indicates more severe impairment/worse outcome

  2. Patient's Global Impressions of Severity (PGI-S)

    Time frame: Pre-post, through study completion, an average of 3 to 4 months

    As CGI-S, the PGI-S is a 1-item global impression questionnaires that allow patients to report their own views on the severity of ongoing symptoms based on a 7-point scale Minimum score: 1 Maximum score: 7 A higher score indicates more severe impairment/worse outcome

  3. Clinical Global Impressions - Improvement (CGI-I)

    Time frame: Through study completion, an average of 3 to 4 months

    Clinical impressions of the client's improvement level that the client shows throughout the therapy (CGI-I) Minimum score: 1 Maximum score: 7 A lower score indicates better outcome

  4. Patient Global Impressions - Improvement (PGI-I)

    Time frame: Through study completion, an average of 3 to 4 months

    PGI-S is a 1-item global impression questionnaires that allow patients to report their own views on the response and improvement to intervention based on a 7-point scale Minimum score: 1 Maximum score: 7 A lower score indicates better outcome

  5. Patient Attitudes with and Satisfaction towards Measurement-Based Care (PAS-MBC)

    Time frame: Through study completion, an average of 3 to 4 months

    A 12-item tailored questionnaire was created to fully capture clients' attitudes towards and experience with measurement-based care during their treatment.

    Minimum value: 12 Maximum value: 60 Higher score indicates better outcome/more positive attitudes toward measurement-based care

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Collaborators

  • Virginia Polytechnic Institute and State University

Registry information

Official study title

An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders

Acronym: MBC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.